A phase II study of S-1 plus resminostat for biliary tract cancer

A double-blind, randomized phase II study of S-1 plus resminostat versus S-1 plus placebo in patients with platinum-gemcitabine combination refractory biliary tract cancer (BTC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223827

Enrollment

100

Registered

2018-02-28

Start date

2018-03-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

biliary tract cancer

Interventions

investigational material(s) Generic name etc : YHI-1001+S-1 INN of investigational material : YHI-1001:Resminostat, S-1:tegafur, gimeracil, oteracil potassium Therapeutic category code : 42- Antineop

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with unresectable/recurrent BTC (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or carcinoma of the ampulla of vater) 2. Patients who have received only one regimen systemic chemotherapy with platinum-gemcitabine for BTC 3. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 4. Patients who are able to ingest agents orally

Exclusion criteria

Exclusion criteria: 1. Patients who have taken HDAC inhibitor 2. Pregnant women, lactating mothers or women of childbearing potential, or patients who are not using adequate contraception 3. Patients with brain metastases or suspected brain metastases based on the clinical symptoms

Design outcomes

Primary

Measure	Time frame
efficacy PFS	—

Secondary

Measure	Time frame
safety efficacy OS, RR, DCR, Safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026